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Cube Navigator is a non-invasive software intended for planning the needle trajectory of CT-guided, percutaneous punctures using DICOM-images and a Navigation Cube attached to a patient. It is indicated for the planning the needle trajectory of CT-guided, percutaneous punctures for therapeutic and diagnostic purposes. The software's functionality allows to automatically recognize orientation, position and type of the Navigation Cube present in the DICOM-images and to manually define virtual needle trajectories to a physician-identified target through the Navigation Cube. Based on this planning, Cube Navigator provides physician information for such purpose. Cube Navigator can only be used in combination with a Navigation Cube, specifically, either the Access Cube for instruments 10-20G (article number mt-ac-ct-20, Class 1 exempt, product code GDF) or the Puncture Cube for instruments 18-22G (article number mt-pc-ct-25, Class 1 exempt, product code GDF). Cube Navigator is a standalone software that integrates the CE-marked and FDA-cleared diagnostic Medical Imaging Viewer medDream manufactured by Softneta that provides all DICOM-related functionality like displaying and manipulating DICOM-images. The Cube Navigator is intended for interventional radiologists, who perform CT-guided interventions for therapeutic and diagnostic purposes. The intended use environment is the CT control room, which can be in a hospital or a medical office.

Cube Navigator is a non-invasive medical device software used in interventional radiology for planning the needle trajectory of CTguided, percutaneous punctures. Cube Navigator provides planning functionality for needle placement through a separate device, called a Navigation Cube. Cube Navigator allows the user to register the Navigation Cube in a feasible needle traiectory using a virtual needle. Based on this planned trainctor displays needle depth and the enty points on the Navigation Cube in its user interface. The Cube Navigator software is only used for planning the needle trajectory, but requires a CT-scan with a Navigation Cube mounted on a patient for the purposes of visualization. Navigation Cubes are sterile, disposable needle quides which are attached to the planning scan is acquired. Currently two variants exist: Puncture Cube or Access Cube, both Class 1 exempt, product code GDF. The Navigation Cubes support the use of needle sizes 10-20G (Access Cube) or 18-22G (Puncture Cube), Needle length is dependent on the trained from the displayed needle depth. Cube Navigator detects which Navigation Cube is present in the takes the average of the supported needle diameters for that Navigation Cube when calculating the thickness of the virtual needle. Cube Navigator is a standalone software that integrates with the CE-marked and FDA-cleared diagnostic Medical Imaging Viewer medDream manufactured by Softneta (Class II, K22232), see Software Architecture Design Cube Navigator for integrated version). Gube Navigator allows the user to access the functionality of medicing images locally or through a remote DICOM-connection, by viewing and manipulating DICOM-images through the user interfaces of the Cube Navigator, as well as accessing the functionality of Cube Navigator itself. The DICOM integration is part of the base software package medDream (see the Statement recarding the DICOM-Standard - Cube Navigator for detailed information about DICOM conformity). Cube Navigator as well as the Navigation Cubes are manufactured by Medical Templates AG. medDream is manufactured by Softneta and for the described purpose, distributed by Medical Templates AG as bundle together with Cube Navigator. When the user installs Cube Navigator, medDream is also installed, without any additional installation or configuration necessary.